To evaluate the efficacy of Helicobacter pylori eradication therapy with respect to objective regression rate and time to disease progression of primary low-grade gastric MALToma.

To estimate any differences in therapeutic efficacy related to different stage of disease,eg. stage IE v.s. stage IIE-1.

To identify the causes of treatment failure, such as the stage of tumor, the presence of large cell component, and/or persistent, reactivation or reinfection of H. pylori etc.

Eligibility

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

The patients must have histologically confirmed primary low-grade B-cell lymphoma of MALT of the stomach which including the following types : diffuse small lymphocytic, diffuse small cleaved, and some diffuse mixed small and large cell types by Working Formulation (Harris NL et al. 1994)(20).

The diagnosis of primary gastric lymphoma must fulfill the criteria of Dawson :

Predominant of alimentary tract lesions with any adenopathy corresponding to accepted lymphatic drainage route; and

No involvement of liver or spleen except by extension of contiguous disease .

The monoclonality of B-cell must be confirmed by either immunohisto- chemistry (light-chain restriction) or molecular technique (IgH rearrangement).

The patient must have no prior chemotherapy or radiotherapy for his/her gastric MALToma.

Patients must have evaluable disease by endoscopy and the nodal status by computed tomography. Endoscopic ultrasonography (EUS)* is optional and for reference only.

H. pylori infection will be evaluated by the following tests: histology, rapid urease test (CLO-test), and serology C13-urea breath test (UBT) and bacterial culture* are optional and for reference only.

The following will be considered to have H. pylori infection : at least two of the following 3 tests show positive results, rapid urease test (CLO-test), histology and serology.

For C13-urea breath test, rapid urease test and histology to examine H. pylori, the examination must be performed at least 4 weeks apart from the latest antibiotics or non-steroid anti-inflammatory drug ingestion.

Patients must have either stage IE or IIE-1 disease, according to an adaptation of the Ann Abor staging system modified by Musshoff for primary extranodal lymphoma.

Patients who had a history of allergic reaction to Amoxicillin and Erythromycin /Clarithromycin are not eligible.

Patients whose cardiopulmonary status not allow him/her to have repeat endoscopy are not eligible.

Patients who had prior surgery, chemo- or radiotherapy for their primary gastric lymphoma are not eligible.

Patients who had previous anti-H. pylori therapy are not eligible.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201422